Authors:	Singer, Susanne Hammerlid, Eva Tomaszewska, Iwona M. Amdal, Cecilie Delphin Bjordal, Kristin Brokstad Herlofson, Bente Santos, Marcos Silva, Joaquim Castro Mehanna, Hisham Fullerton, Amy Brannan, Christine Fernandez Gonzalez, Loreto Inhestern, Johanna Pinto, Monica Arraras, Juan I. Yarom, Noam Bonomo, Pierluigi Baumann, Ingo Galalae, Razvan Nicolatou-Galitis, Ourania Kiyota, Naomi Raber-Durlacher, Judith Salem, Dina Fabian, Alexander Boehm, Andreas Krejovic-Trivic, Sanja Chi, Wei-Chu Taylor, Katherine Simon, Christian Licitra, Lisa Sherman, Allen C.
Title:	Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale
Online publication date:	4-Aug-2022
Year of first publication:	2022
Language:	english
Abstract:	Purpose The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. Methods In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. Results From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from − 3 to − 14. Conclusions For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.
DDC:	610 Medizin 610 Medical sciences
Institution:	Johannes Gutenberg-Universität Mainz
Department:	FB 04 Medizin
Place:	Mainz
ROR:	https://ror.org/023b0x485
DOI:	http://doi.org/10.25358/openscience-7499
Version:	Published version
Publication type:	Zeitschriftenaufsatz
License:	CC BY
Information on rights of use:	https://creativecommons.org/licenses/by/4.0/
Journal:	Quality of life research 31
Pages or article number:	841 853
Publisher:	Springer Science + Business Media B.V.
Publisher place:	Dordrecht u.a.
Issue date:	2022
ISSN:	1573-2649
Publisher DOI:	10.1007/s11136-021-02939-6
Appears in collections:	JGU-Publikationen